On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups, unions, and retirees, submitted a letter to U.S. Trade Representative Robert Lighthizer to raise serious concerns that the recently renegotiated version of the North American Free Trade Agreement (NAFTA) – now proposed to be called the U.S.-Mexico-Canada Free
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”) discretion under 35 U.S.C. § 325(d) to deny institution of an AIA trial when the same or substantially the same prior art or arguments were previously presented to the United States Patent and Trademark
Recently, Pfizer was denied institution of two follow-on inter partes review (IPR) petitions, IPR Nos. 2018-00330 and 2018-00331 (“the 2018 petitions”), filed on December 18, 2017, asserting invalidity of Genentech patents, U.S. 6,339,142 (“the ’142 patent”) and U.S. 9,249,218 (“the ’218 patent”). The Patent Trial and Appeal Board (“the Board”) denied instituting the IPRs using
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that Amgen has brought against Apotex under the Biologics Price Competition and Innovation Act (the “BPCIA”), based on Apotex’s abbreviated biologic license applications (“aBLAs”) for biosimilars
In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine of equivalents claim made by Janssen Biotech (“Janssen”) with respect to a Remicide®-related patent would ensnare the prior art.
Janssen makes Remicade®, a biologic drug whose active ingredient is the monoclonal
On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz International GMBH (collectively “Sandoz”) in the district of New Jersey alleging infringement of two patents related to Humira®: U.S. Patent 9,187,559 (“the ʼ559 patent”) and U.S. Patent No. 9,750,808 (“the ʼ808 patent”).
According to the complaint
The PTAB recently instituted a second IPR of US Patent 9,296,821 (“the ’821 patent”), which covers certain uses of Rituxan® (rituximab), a monoclonal antibody marketed by Genentech and Biogen Pharmaceuticals. The ‘821 patent claims methods of treating low grade or follicular non-Hodgkin’s lymphoma (NHL) by administering rituximab during a chemotherapeutic regimen of cyclophosphamide, vincristine, and
U.S. Patent No. 8,329,172 (“the ’172 patent”), a Biogen-owned patent covering a treatment regime for low-grade B-cell non-Hodgkin’s lymphoma, has been a relatively frequent subject of our posts. We first wrote about it in March of 2017, reporting on the filing of Celltrion’s IPR petition against the patent, then again that May, reporting
On July 2, 2018, Genentech filed suit against Eli Lilly and Company (“Lilly”) in the Southern District of California alleging Lilly’s Taltz® infringes newly issued U.S. Patent 10,011,654 (“the ʼ654 patent”). According to the complaint, the ʼ654 patent issued at 12:00 am Eastern time on July 3, 2018, and the complaint was filed immediately thereafter.
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents covering Rituxan® and Herceptin® were non-infringed, invalid, and/or unenforceable. Genentech responded by moving to dismiss, arguing that Celltrion’s claims were statutorily barred by the BPCIA. As we reported here, the Court agreed with Genentech and